Making the decision about enrolling your child: parental consent

Before you can give consent for your child to take part in a trial it is important that you are given enough information to make an informed choice and an opportunity to ask as many questions as you like. Staff cannot enter your child in a trial if you do not give your consent. The UK Clinical Research Collaboration booklet on ‘Understanding Clinical Trials’ (see resources),has a checklist of questions you might like to ask. You can print off the pages which includes space to jot down your own notes (see ‘Information parents receive when invited to enrol their child’ for more information).

You will also be given an information leaflet or ‘patient information sheet’ which you can take away and read. If you decide to enrol your child, you will be asked to sign a consent form to say you agree to your child taking part. Depending how old they are and how much they can understand, your child may also be involved in the decision-making process

Dr William van't Hoff is Co-Director Medicines for Children Research Network.

In clinical trials for adults, the adult gives consent to take part. But for children taking part in studies the situation is very different, because the consent is given by an adult parent or carer who is not themselves the person who is going to undergo the trial and the benefits and the risks. So the situation is different. And researchers need to explain that carefully to families to under-, to, ensure that they understand that. Of course parents and carers consent for their child’s care in general, and this process of consent is similar for research. But it’s important that they receive and understand carefully the written or other information that’s provided to them, so they’re clear which parts of the care are research and which parts are part of routine care. Older children who understand what is being suggested can also take part in the process of agreeing for research. We call this assent, and it’s a process whereby a child gives a positive response about taking part in research. And this concept of assent varies actually from different countries. Some countries don’t even recognise it. And the age at which assent is appropriate varies from country to country. But in general terms, assent is something, is a process that should be sought by a researcher in a child who has a, an understanding of the research process. It’s also important to recognise that this process of consent and assent is an ongoing process. It’s not just a one-off ‘yes’ at the time of signing a piece of paper. It’s ongoing through the study and can be withdrawn at any stage, and researchers will respect that.

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Age at interview:

47

Sex:

Male

Background:

Gary, aged 47, is married with two children. He describes himself as White British and works part-time. His son was diagnosed with diabetes at the age of four years, he is now 13.

We went to an appointment at the children’s hospital in [area], the diabetic part of it. And whilst we were waiting I think a diabetic nurse came up to us and asked us if we wanted to take part in a trial. Me and my wife agreed, you know, because anything to help diabetic children, research, anything like that. We were briefly explained what would be involved. We’d get sent a questionnaire which, one for me, one for me and [my wife] and one for Danny, which we’d each have to fill in separately. Briefly explained what it was about. And that was it really. There was nothing invasive about it. It was just, you know, half an hour out of our time towards something, towards, you know, this report that they were putting together. That was it basically. There was nothing difficult or, you know, like I say, invasive or anything about it. So that basically was it.

Do you think that made a difference, that, that it wasn’t invasive?

Yes, it did. Because over the years with Danny there’s been an awful lot to take in and we’ve had to take on board a lot of stuff. It’s changed Danny’s life and our lives. And we just want things to, you know, be on an even keel. We don’t want things to, you know, disrupt anything, you know, go out of our way to do things. We like to like keep Danny as even as we can without disrupting things.

If it had been a change of treatment, would you perhaps have thought more about it, do you think?

Oh, yes, we, yes, we would have done. We would have definitely thought more about it. Whether it meant like having less injections every day or no injections or an insulin pump or any, anything like that, yes.

Yes, or the method of delivering –

Yes, the method, yes.

-- the insulin.

Yes, if it’s like needle free. Or anything, yes.

But would you consider other trials though, even if they were…?

I think we would, yes, yes. But I’d need more, rather than a questionnaire, if it was to like involve his dosage or his; changing of his dose we’d need more than just a questionnaire. We’d have to have like a visit or something or go somewhere to see somebody rather than just getting a letter and signing it. You know what I mean?

Alison talks about being invited to a growth hormone trial for her son. She found this a difficult decision to make, knowing that nothing is medically wrong with her son, but also recognising that, as they are a minority group of children, it's important that researchers can find out more about the condition.

Alison, aged 39 years is White British, works part time as a music teacher and lives with her husband and three children. Her son was diagnosed with Intrauterine Growth Restriction around 22 weeks. Alison gave birth to her son at 30 weeks; he weighed 2lbs.

Because our child has never caught up in height and weight, we were suitable, should we want, to go ahead with growth hormone treatment, which we opted to. And at that stage, once we said yes, we were then asked whether we’d take part in a clinical trial. Now that, you know, that was a slightly harder decision in many respects to make because it has been costly in terms of time really, which is why we’ve decided not to go any further with it. So our child has growth hormone treatment, treatment which is inject, he’s injected with growth hormone daily to make him grow at a normal rate. And in the first year there’s some uncertainty as to the best dosage, and models are different in America as they are from Europe. So we were part of a trial to see which dose is the best really. Now as it happens we were given the lowest dose, which is great, great for us. And so far it looks like children do very well in their first year on the lowest dose actually and don’t need to be put on a higher dose. So we went into that with a little bit of anticipation because obviously I don’t know what dose before, we, you know, what we were going to be given and I don’t, you know, like most parents you don’t want to inject your child with some synthetic growth hormone if, if you don’t need to.

So that was a little bit more, “I can’t quite see the benefit for us” but I can see the bigger picture in that, you know, ten years down the line this needs to be more finely tuned as a treatment. And although growth hormone, as far as I understand, has been used in the UK for quite a while, it still, well, certainly it still feels a little bit embryonic at, at times. And, you know, for example the best dose for a 4-year-old isn’t standardised. So that was a bit harder. And we went into it thinking, “Well, actually if we’ve signed up to this” which we have, because we signed up to injecting him with growth hormone till he’s 18, “it’s, it’s a big commitment.”

And that was a hard decision to make because the only benefit is that our child is going to grow and not be extremely small in size and height. You know, there’s nothing medically wrong with leaving him small but, you know, we have decided to do it, really from a social point of view. So then to take part in a trial whereby it felt, you know, slightly like these dosage levels have still, you know, still need tweaking and it seems a little bit uncertain was much more, you have to think of a bigger picture as I say. So ten years down the line it will be really nice for children going through this to know, I don’t know, the medium level of, you know, that’s where you need to be or, you know, and for people to have a much bigger picture. And my feeling is, and it might be wrong, there are not that many children, you know, go, you, through the process we have. Most do catch up. So these small for, you know, small for, small for gestational age children, there aren’t that many of them about, although I might be wrong. So actually it’s really important that they try and catch us and get us to be part of it.

Although many of the parents we talked to were happy to give their consent, for some it was also a worrying time. Feelings when first approached varied from uncertainty about the trial to feeling a sense of control. Parents’ first instinct is to protect their children, and they were very aware of the responsibility of making a decision on their behalf.

Linda, aged 43, is White South African, works part-time as a Staff Nurse, is separated and mother of three children; all born in the UK; ages 7, 9 and 15 years. Linda's youngest child was diagnosed with a heart condition 12 hours after she was born.

Okay well my little girl was born at four minutes past midnight on the 23rd July 2001, and by 11.56, I remember it rather well, a nurse listened to her chest to see if she, for her well baby check to see if she could go home, and they said she couldn’t and their precise words were; “There’s something not quite right with your baby”, which is not really words a mum wants to hear, you know, after hour long of waiting and labour and things. So she was referred to a cardiologist the next day, and diagnosed with a [heart valve problem] aortic valve which is a fairly common heart condition apparently it’s the most common childhood sort of heart condition there is. It’s a big one to fix but about one in about every 100 people have one but probably don’t know that they have one, that’s what research has shown. She was sort of followed up fairly regularly at the hospital where she was born by their fantastic cardiology team. And I was then approached by one of the directors of intensive care, or the Director of Intensive Care, to see if I would take part in a trial for a drug, which name has completely escaped me, its [Res] something like that. It’s, basically it’s a drug for RSV [Respiratory Syncytial Virus] which is a respiratory virus that children get. And it had already been licensed and that for me I think is a very important part because had it not been licensed I might not have been as keen for her to take part. But because it had already been licensed I knew it was tested and safe.

I think getting your head around the fact that you have a cardiac child and then getting your head around the fact that some doctor wants to take blood and poke your child was making it difficult for him to find suitable parents.

I was going to say at the time, you know when you sort of took part did you feel sort of vulnerable?

No actually for me it was more of an empowering thing. Because I thought well I’m actually here being able to take control of something, you know. I’ve got a say finally in something that happens, up to then I had had no say in anything it had all been based on, you know, what they wanted to do, doctors wanted to do rather than what I wanted to do, so.

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Age at interview:

38

Sex:

Male

Background:

Chris aged 51 and Nikki aged 38 are White British, married with four children ages 8, 6, 3 and 10 weeks. Chris is a retired fire office and Nikki is a housewife. Their eldest daughter has severe asthma and a severe adrenal deficiency.

And, and how does it feel sort of consenting for your daughter to take part in something?

Because we, we understood it was for her benefit, you know, whatever the results would have come out, if it had come out and said that her immune system was fine, to us, to be able to have that sort of test done, was great because, you know, putting your mind at rest over your child is important. So not only are you saying, like consenting and giving her things and blood tests and that, but it’s, its means to an end, isn’t it? It’s not for nothing. It, you know, it’s helped her. It’s possibly helped other people. It, I’m all for that.

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Age at interview:

38

Sex:

Male

Background:

Chris aged 51 and Nikki aged 38 are White British, married with four children ages 8, 6, 3 and 10 weeks. Chris is a retired fire office and Nikki is a housewife. Their eldest daughter has severe asthma and a severe adrenal deficiency.

Nikki' Sarah was diagnosed as being asthmatic when she was 18 months old, and at that point we then tried a whole range of preventer inhalers but none of them seemed to get her asthma under control. And when she was about three we switched to a, a drug called Seretide. And Sarah was on very high doses of Seretide and we did have concerns about her immune system and whether it would, it would impact on it or not. And then when she was about 5 we noticed that she was ill all the time. She was constantly ill. And we mentioned it at the hospital, this was in the, the December 2008, and, and we said we were quite concerned. But they seemed to think children get viruses all the time, so it was quite normal. But we, we made a note. There was two things. We made a note from the, the December to the March when she next went back to hospital of all the times that she was ill. And, and in that time she just, she had septic tonsillitis, three lots of conjunctivitis, two chest infections, a, a vomiting bug. She was just constantly ill. And we also noticed that she, whereas the, the other children or us would, might get one of the illnesses, she would have it for a longer period of time. And the other thing that we noticed was that she was, although one of the oldest children in a, like a pre-Brownies group that she went to, she was the smallest. And we’re quite tall, so that again concerned us. So when we went back to hospital and we put all this to them, the height thing was the thing that made alarm bells ring.

And so we were told that there was a, a clinical trial going on, which we had been asked to do the previous year. But, but Sarah had, had had blood tests done at the hospital a little bit before that. And because they were in a rush they didn’t put any Emla cream on her, and they, they just tried to get a vein and couldn’t get it and she was in a terrible state. So that in her head; “blood test” there was no way. So when it was explained to us that there would be a blood test involved, at that point Sarah refused point blank and we weren’t about to force her to do it. But when, when we mentioned the illness and the height, the hospital did advise that to put our mind at rest we could take part in a trial which would do two things. It would help out with the trial and it would put our mind at rest that she was just a normal girl having illnesses. So we were introduced to the nurse, who came out to the house first of all and sat with Sarah and explained exactly what the trial involved and that, “Yes, it did involve a blood test” after the three days, but that she would have her own Emla and so could put it all over her arms and her hands. And we had a trial with the Emla as well. When the nurse came out she showed us. She put it on her hand and her arm to let her see that she couldn’t feel anything, which put Sarah’s mind at rest.

And they said, you know, “It is possible that the Seretide has had an effect, but unlikely.” But they said by going on this trial it would put our minds at rest or, you know, or find out that she had something and be able to get it sorted, and it would also help with the trial. And at, at that point we thought it was, it was important to know because she was so very ill all the time and, as I say, the height thing did ring alarm bells with us, that we then were able to persuade her. And, as I say, the nurse came out and showed her with the Emla that it really wouldn’t hurt her.

And the nurse who came out was, was really lovely with her and explained it all and said, you know, “If you’re not happy at any time or you change your mind, it doesn’t matter and, and you can just do that at any point.” So she was a lot more willing to do it then. And, as I say, we were getting quite concerned as well, so we were probably a bit more not forceful but, but –

Chris: Cajoling.

Nikki: - trying to sway her a little bit more in a positive... The last time it was just, “It’s a trial and we’ve said no and it doesn’t matter.” But we, we sort of wanted to know for our own minds as well whether the Seretide was having any sort of effect. Because, as I say, she was just constantly ill and they were major illnesses. You know, septic tonsillitis when you’re 5 is, or any age it’s awful, but when it’s just followed a chest infection and it follows something else, we wanted to know was this normal and, and she was just a normal child getting ill, or was there something we could do about it? And it has turned out that there was something we could do about it.

In Nikki and Chris’s case the trial was to find a non-invasive screening tool to determine if children with asthma who take inhaled corticosteroids are at risk of adrenal suppression (when the adrenal glands do not produce enough steroid hormones to regulate organ function). As a result of tests taken during the trial, it was discovered that their daughter had severe adrenal insufficiency and required urgent medical treatment. Nikki says “But we were told that it was only thanks to doing that trial that we found out. Basically her life was in danger and we had no idea until we’d done this trial what was wrong with her”.

Kathryn is aged 39 years, is White British, married with two children and has full-time employment in the health sector. Her 14 year old daughter was diagnosed with diabetes at the age of 11.

Just to give you a bit more time, I suppose, to think about it. Don’t expect to give it you, to, an answer on that day. And give you a bit more written information rather than verbal. And just a bit more time, even if you’re just sending it through the post, just give more time to think about it and read it. Yes, definitely, because I, and I’m not, I suppose I’m not alone, I don’t take a lot in just by being talked at. I do need to, definitely to read it and think about things. And, yes, I would have probably still done it. But I might have remembered it a bit more [laugh]. Well, it is and because you are there with your child and you are in that environment of where you’re going to check up how she is, your mind is at other places. Especially over the year where she’s not been 100 per cent and she’s only just in the last like three, four months got on a good level with her blood sugars. So the, at the beginning of that trial I probably was a bit like, my mind was probably somewhere else. Because I did have a lot of questions to ask, but not her, ask the doctor. So your mind is somewhere, so you probably don’t take it in like you should really. Whereas if you get a piece of information to take away, it doesn’t really matter, does it? Because you can read it at your leisure then, can’t you? And then, because my husband wasn’t there for, for any of them, because he struggles to get, you know, to these appointments. And then you’ve got time to discuss it with your partner as well then, haven’t you? And then it gives, because you sort of feel like you’re putting your child on the spot really as well, if I’m honest, because they wanted a decision there and then. Whereas if, if you go away, yes, you still probably would anyway, but it just gives her a bit of time as well, rather than just me. It gives her a bit of time to think about it as well, doesn’t it? And you talk to her as a family really then, don’t you? And what you, what you’re doing it for and what you expect to get out of it. Whereas I think until talking to you I’ve not really thought of it like that, not at all. We just did it, you know, answered the questions as best we could. And then when it finished I just, it finished. I never give it a thought after that. I think that it’s wrong that I thought like that, if I’m honest with myself. It’s wrong that I thought [mhm] until today. “What have they done with that?” I’ve not thought that at all, not at all. I mean she were a lovely nurse, really nice lady.

How parents were approached was important at a time when they may be feeling vulnerable. For parents who had worked in healthcare or research, this helped them to understand the process of recruiting people to trials and consent and they felt it made them more likely to take part. However one parent who is a nurse and whose husband is a doctor thought having a health professional background might lead researchers to make some assumptions. She said, “I’m a nurse so he [Consultant] thought he could appeal to our medical sentiments to let us take part.”

In all cases and situations and however little time is available to make a decision, there should never be any pressure on parents to give consent for their children to take part in trials. All the parents we talked to recalled being told it was their decision, and most remembered being given plenty of information and explanation about the trial without influencing their decision. On occasion parents sensed that health professionals were really hoping they would say yes, even if they didn't say so out loud. As Alison says, “There was a research nurse who was extremely helpful and made herself extremely available, but also very obviously wanted us to sign up”. Parents may feel unspoken pressure to be helpful.

Alison, aged 39 years is White British, works part time as a music teacher and lives with her husband and three children. Her son was diagnosed with Intrauterine Growth Restriction around 22 weeks. Alison gave birth to her son at 30 weeks; he weighed 2lbs.

How did it feel sort of being approached to take part in a trial at a time when it was kind of vulnerable?

Yes, it’s difficult, isn’t it? And it, and it’s one of those kind of difficult things when you’ve got someone in crisis yet you need really to get a signature off them ideally. And I could see that in the staff. I think part of my willingness to; to take part was that everyone was incredibly nice. And I mean the neonatal care we received was absolutely excellent, first rate. And I think that probably kind of helped us warm to being compliant and easy-going parents as, as far as all that happened. And I was also in the same hospital for my pregnancy, and again I had absolutely excellent care from the fetal medicine department. So we felt, not that we owed the hospital something. That was wrong. But, you know, that there was certainly a kind of bit of, well, you, we have been treated, you know, like royalty and they have kept a child alive which, you know, could have easily have died, and everyone has worked their hardest and absolutely done beyond their call of duty. So actually, do you know what, we can do this, because we can see that it’s something that really matters to them. Had I not had such positive experiences I might not have been. I think possibly, but I don’t, it’s difficult to say, isn’t it? But certainly the atmosphere and the approachability really by the consultants, so, you know, very senior doctors making themselves very, very approachable and explaining things very well certainly had a part in me saying, “That’ll absolutely be fine. Of course we’re happy to help.”

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Age at interview:

39

Sex:

Female

Background:

Alison, aged 39 years is White British, works part time as a music teacher and lives with her husband and three children. Her son was diagnosed with Intrauterine Growth Restriction around 22 weeks. Alison gave birth to her son at 30 weeks; he weighed 2lbs.

I think one of the things they talked about a lot was that these things quite often happen at an absolutely crunch, critical time. You know, you have a child, a baby in a neonatal unit. I mean your life quite often is in terms of crisis. How then you begin to make a decision, if you do make a decision, and how best it is to approach parents, and what information you give them and what information you don’t give them. And how much somebody needs to know is probably different to the person in the next cot. And I think also for us a big thing was how much you trusted the doctors. Which sounds an awful thing to say but, you know. And personality plays a part, you know. Is it somebody you like? And you are trusting them with your child’s life, you know, and you don’t have a choice about it. It’s a choice that’s forced upon you. And I think that has a big part to play. And I think I hinted at that at the beginning on the atmosphere that’s created. Certainly I felt more than happy with the level of care we had, which I think was what has endeared us to kind of be part of things. And, and I’m sure had that not been there then I wouldn’t. But I think trust is a huge thing, you know, a really huge thing, and how doctors build up trust with parents. Which they need to do anyway, but actually if you want a parent to sign a form you’ve got to work twice as hard at it as well.

How they choose to communicate. I never felt, I have to say, I never felt if I didn’t do the trial we wouldn’t be treated well. I never ever felt that that came in to the equation. And I jolly well hope it wouldn’t. But I, I never felt that. So I felt we were making a choice. But how freely you make that choice, I’m not sure. Because I think subconsciously….

….at some level you must surely think, “Actually if I agree to this, then I’m being compliant, I’m being a compliant patient, maybe I get better care.” And I know it doesn’t work like that, but I’m sure, I you know, I don’t know how free I am from that thought and how much, it, and I think that’s quite a natural thing, isn’t it, you know. Oh, I don’t know, maybe it is for me and my personality. But, you know, if, if you agree to what somebody’s doing, life is going to be better for you. Because generally it is, isn’t it? And I’m not, I really don’t know how much that has a part to play. Even though I’d like to think that for me my choice was entirely rational, I doubt that it was, you know, I really do.

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Age at interview:

28

Sex:

Female

Background:

Jo is aged 28 years, married and is a full time housewife. Jo has two children. Her eldest son is 8 years old and was diagnosed with having migraines aged 6.

So when he got to about, I think he was about 7, we took him again to the doctor’s and they finally referred him to the hospital and said, “Obviously it’s more than just your average headaches.” We took him to the hospital, that had just opened a new department, took him in to see one of the, the under, the younger doctors in there. They, they basically said at his, at his age there’s nothing they can do, “Try giving him Calpol.” Again we were like, but our concern was it was getting worse to the point where he wasn’t just sick for a couple of hours now; it was twenty-four hours. And he, he also had eye problems, so he was already under the hospital for that. The doctor sent us away with, and said, “Come back in three months’ time and we’ll assess him again.” And then the day after that appointment we got a phone call from the same doctor saying that, who is Dan’s trial doctor, was interested in meeting him. He wanted to, us to go back to the hospital. Would we be interested in a trial for medication as a preventative rather than….

At the time we were very sceptical of putting him on a trial. He was only; I think he’d just turned 8. Might even have been younger, he might have been 7 at the time. And it was like, “Is it really something we want to do? Put him on a trial for medication that we don’t know what it is and we don’t know what the side effects are?” Also he was due to have an operation on his eye at the same time. But we agreed to go and meet the Doctor and the nurses just to, to get an idea of basically what it was that the trial was about. If it could help him, how long he’d be on the tablets for, what would happen after the trial finished, would he then have specialist help? I think my main concern was because of my brother, so it is a family thing, my brother had migraines. Started off when he was a young child like Dan and now when he has one they last over a week and he can’t get out of bed for a week. And I think in the back of my mind that was always, “I don’t want that for Dan. I don’t want him to be unable to do things because of something that maybe we could have prevented or helped.” But it, it was a big choice to even just go along really and meet them. Because putting yourself on a medical trial is one thing, but choosing to put a child on one is a bit different.

So when this trial, so when we were approached for the trial and they were like, there were these drugs, and I was like, “Well, why weren’t we offered them before if they’re there?” To which they said, “Well, we only use them on adults.” And I was like, “But are they safe to use on children?” And they said, “Yes.” I think it was just more a case of Dan was having them quite frequently, they were taking him away from school, they were making him really poorly, we had his eye operations on top of it all, and we, I think we felt that being part of the trial, if he was on the drugs and they worked, it might give him a break for a little while. But in, in the end I think it was down to the fact that his doctor and his nurse were so reassuring. That they’re the reason I think that we did agree to go on it. And it wasn’t a pressure. There was no pressure in it. They agreed that, well, they were going to take care of Dan regardless of whether or not he was on the trial. And it was nice to have a specialist doctor that was willing, whether Dan wanted to be on the trial. They gave Daniel the choice as well. They explained it to Daniel and sat him down and talked to Dan about it. We’d already done it but, you know, but not a lot of doctors do that, in all fairness, treat a child as their patient. They always speak to the parents. We’ve had that a lot before in the past. So they made him reassured, which made us reassured. I think that’s probably why we chose to in the end. And plus the fact that it wasn’t a set-in-stone thing, and if we weren’t happy we could just pull out, but we could pull out and still have their support. So I think that’s, that made us decide that, that was for the best.

Clinical trials are done because there is a possibility that a new treatment will be better than the existing or comparison treatment, and it may have already been shown to work for other conditions or other groups of patients. However, trials are just as likely to find that new treatments are worse than existing treatments. Parents who desperately want their child to get better may interpret doctors’ words in a way doctors do not mean, or, ‘read between the lines’. This underlines the importance of staff being very careful about what they say and how. Parents may feel that there are benefits from participating, such as extra monitoring and appointments, or a feeling of helping others. However, parents need to make these decisions based on unbiased information about the trial.

For many parents it was important to make the decision with their partner and some parents talked to family members. When Alison’s son was in neonatal care it was a very difficult time and although she was happy to consent for her son to take part in a trial, she could not have made the decision by herself.

Alison, aged 39 years is White British, works part time as a music teacher and lives with her husband and three children. Her son was diagnosed with Intrauterine Growth Restriction around 22 weeks. Alison gave birth to her son at 30 weeks; he weighed 2lbs.

You know, for me a decision I never made it alone; I made it with my husband. I think if I’d had to make it alone, I would have had to have, call on friends, you know, who are academics, you know, who, who do this professionally for a living, to say, you know, “Is, is this okay?” you know, “Is what I’m signing up to all right?” And I think definitely I needed to have backing of somebody behind me to feel confident and comfortable in my decision. It wasn’t something I could do by myself. And I think, I don’t know if we, yes, I, you know, I think the hospitals do encourage that really, is, you know, is a joint decision, not something you make lightly and not something that you make by yourself, but it’s something you make with somebody. And actually you’re making it for the interests of your child as well, you know. There’s a third party involved. And that’s I think, you know.

I think that’s the, sort of the interesting bit, isn’t it? Because when it’s for yourself it’s kind of, it’s a different process.

Oh, definitely a different process, yes. And it’s, it’s far harder when you’re taking on somebody else, when they can’t sometimes articulate or communicate that to you, and it’s far harder.

Yes, yes. It’s that feeling that this is all kind of at a developing stage. Which is slightly unnerving to a patient, I have to say. You do feel slightly unnerved, especially when it’s for your child, not to you. I think if it was for myself, that’s fine. But I think, you know, for any parent, when it’s their child, the maternal instinct to protect no matter at what cost you kind of almost have to override I think. And that’s hard to do. And my guess is that’s why lots of people don’t sign up to things, yes.

In a randomised trial, people are allocated at random to one of the treatment comparison groups, so that each group has a similar mix of people of different ages, sex and states of health and can be compared fairly with the other groups. (See also ‘Why do we have clinical trials in children and young people?’) Randomised trials are done when we don’t know which treatment is best, in other words when the relative merits and disadvantages of different treatments are uncertain. It is important to realise that in about half of trials, the new treatment will turn out to be better, but in the other half it will turn out to be worse.

The majority of parents understood about the need for random allocation (randomisation) to a treatment group. However, when making the decision to enrol their children in trials, first and foremost was their children’s health and safety. When drugs were involved parents wanted to know that they had undergone preliminary testing and were considered to be safe for their children to take part.

Lucinda, aged 37 years, is a single mother to her son Toby aged 10 years. Lucinda describes herself as White British as works fulltime in the legal profession.

What sort of questions did you have?

Well, I was, because you don’t know what medication Toby was going on. There were two medications that are currently being used for migraine, and the placebo. My concern wasn’t about the placebo, it was about the, the current medication that is being used, side effects and things. But they said they were minimal. I went away, looked at length myself on the Internet. I also had a word with my boss, who’s a barrister and his son is a surgeon, paediatric surgeon. So my boss had a word with his son and he came back and said, “No, it’s fine. They’re both safe. It’s not a clinical trial. They’re already in use. So it’ll be safe for Toby to go ahead.” So I was happy to do that.

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Age at interview:

35

Sex:

Male

Background:

John is married with four children. John left full time employment to become a full time carer to his daughter Chloe who has cerebral palsy and global developmental delay and his remaining children. John describes himself as White British.

You know from their point of view I think you know it could be quite useful, moving forward. Our thought process at the time was basically you know, if it can put a process in place that means that you know other kids that go through the same cause of events are here for less time and their time is more comfortable then that’s got to be a benefit to all, you know. It’s not, it wasn’t ever going to put Chloe in any detrimental impact, you know all it could do really would be to keep a closer eye on her as opposed to a less involved care if you like I suppose. But I guess at the end of the day if the medical world was perfect you wouldn’t need research and trial and errors and so forth.

Yeah, basically they put Chloe’s details into their database on the computer and it just churns out which one she’s going to be on, it’s not you know it’s kind of like just putting a bunch of stuff in a hat and picking one out and going “Yeah, that’s it then”. So it’s fairly straight forward, it’s not rocket science really.

Well I mean normal control, they let the blood sugar level go to about I think they said eight or nine. Whereas with the tight control it’s, they’re looking at the blood sugar being at something like four or five. So it’s a lot, lot closer. But at the end of the day if it was a normal, well that’s not going to be any different to the treatment she would have had if this trial existed or didn’t, so either way it doesn’t really make a great deal of difference, because you don’t know whether the benefit is there of whether it isn’t. So if you don’t know, you’re not changing anything by leaving it on normal control because that’s what they’d normally do anyway.

Yeah, no, definitely, yeah, no, I mean everything was gone through in quite a bit of detail. More detail than probably than we really wanted. It was “Do you want to do this? There’s no impact on Chloe as such”, fine, knock yourself out. You know, we’ve done a couple of couple of trials on various things with Chloe over the years and you know, I think at the end of the day you know, with the way you know the NHS works and the problems they have where funding is concerned etcetera, anything that’s looking at progressing things further forward and making life easier for everybody in the future has to be worth looking at. That said if they started saying “we’re going to take a lung and you know have a look at that” then that’s a little bit more of an issue isn’t it. You know because if it’s just let’s take these readings, have a look at it and analyse it then there’s no harm being done.

The parental instincts were to give their children the best care combined with protecting their children against harm.

Linda, aged 43, is White South African, works part-time as a Staff Nurse, is separated and mother of three children; all born in the UK; ages 7, 9 and 15 years. Linda's youngest child was diagnosed with a heart condition 12 hours after she was born.

I was interested in the sort of the consenting to take part really when you know you’re not sure what you’re going to have and that actual yes we’re going to take part anyway.

Yes only because the drug had been tested for the lung patients before, I don’t think I would have taken part had it not been a safe drug.

Yes that was important, that knowing, and trusting that it was safe.

Yes I knew it had been licensed for normal for the lung complaint. I wouldn’t, I don’t think I could have taken part had it been just a completely new drug. For myself I could have but not my child, you know, yes. No I couldn’t have taken a completely randomly untested drug for myself for my child no.

Slightly different to consenting for you than it is for consenting for someone else.

Yes, and especially for your child. The rest of your life you would think if only I hadn’t, if only I hadn’t, you know. It’s, it would be different if her life, if she had say cancer and it was an experimental drug that, an unknown drug that could help her and without it she would have no prognosis and that would increase her chance. This drug was purely for giving her less of a chance of contracting the RSV virus, Respiratory Syncytial Virus I think something like that. And it’s something that cystic fibrosis patients suffer and if she had got it with her heart condition it could have made her very, very ill. There was no guarantee that it was going to help her but I thought if it helped, it increased the odds. But if she had a condition where giving her, taking part in a trial would be her only chance in a way then I could do it. But, you know, if it was say if she had any form of leukaemia or something and the drug that was being tested had a proven success rate but the only way she could get access to it was by taking part in the trial then I would say yes, you know, so. Anything that would increase her odds of survival would be the thing, you know, so.

I mean for us the risks of her taking part in a trial versus the risks of her getting RSV. RSV was by far the worst case scenario. So her getting the vaccine potentially outweighed the risks of, you know, for us that was, you know. Even though we don’t know which one she got and we had no guarantee of her getting it so.

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Age at interview:

28

Sex:

Female

Background:

Jo is aged 28 years, married and is a full time housewife. Jo has two children. Her eldest son is 8 years old and was diagnosed with having migraines aged 6.

What reassured you to take part?

I think I was more nervous, like I say, about, about him being a number who was on a trial and they needed so many children to be on this trial. It was the first trial that had ever been done for children. There’s been adult trials on migraines, but never about children. And that was more like a, “Oh, it’s never been done before.” So, you know, I think the other thing that scared me was every time we went to the doctor’s and said, you know, “He’s really poorly” and they said, “There’s nothing we can do.”

Yes. But I think this trial was made easier for me to put him on because the tablets had been used on adults. I have to admit if they were tablets that maybe hadn’t been used at all; I wouldn’t have agreed to put him on it. But because they were something that, that was, had been used on adults for such a long time, it’s different than putting him on a new to the market drug. And I think that was also a very big factor in that, you know, children’s bodies, they are smaller, but in, in fairness they do run the same as we do. And I, I don’t think I’d have put him on a tablet, if I’m honest, that hadn’t been tried before.

And I think most of the drugs for children are trialed somewhere.

Yes, I think, I think that makes a big difference in especially, like I said, children’s trials. If you’re, if you’re an adult and you’re consenting to take a drug that’s never been put on the market, then that’s your choice to do so. But to choose to put Dan on something that hadn’t been tried on humans before, no, I don’t think I could have done that, regardless of the outcome. I think I’d have been 90 per cent more sceptical of putting him on a tablet that hadn’t been used than putting him on one that worked for adults. So I think that was, we were happy for that.

And they were all explained anyway, that they were tested already?

Yes, they were, they were well-used drugs. Both of the drugs that were in the trial were well-used drugs on adults. They just had never been used, and they, they, they had been used on children quite successfully, but there’d never been a trial to prove that they were successful. And that, that was, I think that was the major difference between putting him on a trial like the one he was on and putting him on a new drug. Which I wouldn’t have done. Because I wouldn’t, I, I think clinical trial; I guess a lot of people would put it down to feeling like a guinea pig. But that, that wasn’t how Dan was made to feel on this. So we were quite happy with everything that went on.

In contrast Alison felt assured that the risk of her son taking part was a “limited risk” because of the strict guidelines on clinical trials in children. However, taking part in a trial can involve extra appointments and tests for your child. Knowing what is involved in a trial and time commitments and money was something that Alison considered before giving her consent.

Alison, aged 49 years, put her career on hold to care for her son who was diagnosed with Cystic Fibrosis soon after birth; he is now 22. Alison now works part time in a School and lives with her husband and second son who is a carrier of CF.

I think it was really it was not so much the level of risk because I think as a child; I was making the decisions when he was a child. [Yes.] There’s not a lot that they can do for children because the guidelines are much stricter I think over involving children on clinical trials. So they tended to be if they did ask you to do anything the involvement was fairly small and fairly not risk free but limited, a limited risk. As I say he mentioned the Flixotide trial well they knew that that was an established drug so it was safe but they wanted to see the, you know, whether it was actually effective. So they knew that if you took that the risk of taking that had already been investigated I guess by whoever makes it prior to it being released as a licensed drug onto the market and they were just then looking into the effectiveness of it. So I think when they are involving a child in a trial it was on a more limited risk basis. So the only decision we really made then was what kind of involvement did it have in terms of how, what tests were they asking you to do. And it was only if they were going to stick a needle into him, when we said “well thanks very much for asking but no, we’ll pass this one by”. It was only when he got older really where he needed to give permission for doing it or consent that the risks probably seemed to become slightly more increased and the actual level of commitment became a bit more increased as well.

Vaccine trials often require healthy people to take part. For these types of trials, most parents we spoke to either received a letter and information about the trial from their local health authority, or an email at their place of work, usually University and NHS employees. The email came with attachments providing information about the trial. Others saw media advertisements. Like parents whose children are ill, parents of healthy children will be weighing up possible risks and benefits before they consent.

Lena, aged 44 years is White British and married with three children ages 11, nine and two years. Lena works part time as a child-minder. Lena consented for her youngest child to receive the swine flu vaccine as part of a clinical trial.

Right so from what I can remember she was up to date with all her jabs. And the swine flu, so the swine flu was just, everyone was just hearing about it, and starting to panic. Not me panicking as such, but it was there was quite a lot of in the newspapers, a lot of I don’t know. They were just drumming it up so it was sort of like scare mongering. So we got this letter from the from the Local Health Authority asking us if we were interested in joining our youngest daughter in the study, because she fitted the age group that was required, which was six months to I think it was four years. I don’t know if I remember correctly. There was different age categories but that was the only category that was required of us. My son who was 11 at the time was desperate to join the study because he was convinced that [he] was going to die of swine flu. But he wasn’t selected, much to his annoyance.

But so my husband and I discussed it. We looked at the information that was sent to us, by there was an address to have a look at the information, and it was very informative. It wasn’t that we were actually being used in a trial as such, because they both, both of the vaccines had been trialled, they just needed to see which one was going to be the most effective for the babies. And obviously they wanted to, I don’t know what their procedure was but they just wanted you to check. So both of them were safe for children, it was which one they wanted to use. Perhaps the cheapest, or don’t know, the easiest available. I don’t know so. So we considered it was safe for her to do it, so which was why we agreed to do the study.

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Female

Background:

Tina is married and mother of three children aged 9, 11 and 18 years. Tina is a self-employed Management Consultant and describes herself as White British.

And just going back to that again, is, is, when you saw that, can you tell me perhaps why you think you were consenting for your children to take part in the trial.

Again, I think it was because there was a lot of chatter in the press that swine flu was going to be a big issue. They, they were obviously in a you know, in a risk group being at school; my son does tend to get things and he keeps them longer than anyone else and so you know, and clearly it was a way of giving them early protection. So it seemed like a sensible thing to do, and to give them sort of, obviously, an insight into a process like this.

That’s interesting. And did you talk about it with anybody or did you just make that decision?

I obviously talked to them to the children because they understood both that it was a piece of research and that it would give them protection. And as I say they were pretty keen on seeing what it was all about. And yes obviously discuss it with my husband as well because vaccine, because with my daughter, she was MMR, right in the middle of that. And so we did go for single doses with her because we were, weren’t sure actually what the, you know, where that one was going to pan out. So giving them vaccines isn’t something that we would do lightly.

You know it’s because it’s not you, it’s someone else. And they although they agreed it’s the long term things you don’t know about.

Yes, exactly.

Yes, so, it is quite a big decision.

It was yes, absolutely you know and we wanted to, and we were balancing the risk of them having what sounded like a very nasty virus with giving them early protection. So, and again all the data seemed to show that this was not an experimental drug, it had been used in adults, it had been used in mainland Europe. It was just simply trying to work out whether either of them was more effective than the other and whether there would be any different reaction in children in this age group. So, it was, it felt like a very controlled risk.

So the level of risk was important?

Yes, yes. And also I think the fact that it was this was not an experimental drug, it was just being used in a different way, in a different age group. It was yes, absolutely you know and we wanted to, and we were balancing the risk of them having what sounded like a very nasty virus with giving them early protection. So, and again all the data seemed to show that this was not an experimental drug, it had been used in adults, it had been used in mainland Europe. It was just simply trying to work out whether either of them was more effective than the other and whether there would be any different reaction in children in this age group. So, it was, it felt like a very controlled risk.

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Age at interview:

35

Sex:

Female

Background:

Rachel is 35 years of age, White British, and lives with her husband and their three children aged three, five and seven years. Rachel works part time as a Research Fellow and trial manager for a Clinical Trial.

Would there have been any reason for you not to have taken part?

There would have been. I’m trying to remember exactly what I went through. I was concerned at the stage, at the level of the trial. It wouldn’t have meant I wouldn’t have taken part, but I wasn’t sure at what sort of phase of trial it was. So I wasn’t sure whether the vaccine had been tested before at all. If it hadn’t, it would have been a very different decision. It would have been something I’d have thought a lot harder about and I don’t know what I would have done. I might have done, I might not have done. But it, given that it had already been tested and had already been licensed for use with children, I didn’t feel that worried about it. The only other reservation I’d have is that I wasn’t even sure I was going to give them the swine flu vaccine anyway, because it had been discussed and talked about a lot. So I had originally said I wouldn’t need to sort of take them to have a swine flu vaccine. So that, I did think about that and I sort of did a bit of literature searching on vaccines. But I think you just get lots and lots of scare stories around the websites. So I just thought, “Oh, no, I can’t be doing with that, so”. There’s very little objective viewpoints on vaccines.